The following data is part of a premarket notification filed by Endo Optiks, Inc. with the FDA for Microprobe Laser And Endoscopy System, Model E2.
Device ID | K042918 |
510k Number | K042918 |
Device Name: | MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2 |
Classification | Powered Laser Surgical Instrument |
Applicant | ENDO OPTIKS, INC. 39 SYCAMORE AVE. Little Silver, NJ 07739 -1208 |
Contact | Keith Hertz |
Correspondent | Keith Hertz ENDO OPTIKS, INC. 39 SYCAMORE AVE. Little Silver, NJ 07739 -1208 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-10-22 |
Decision Date | 2004-11-22 |
Summary: | summary |